Civerán 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Civerán 10 mg film-coated tablets

Loratadine

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Civerán is and what it is used for
2. What you need to know before taking Civerán
3. How to take Civerán
4. Possible side effects
5. How to store Civerán
6. Contents of the pack and other information

1. What Civerán is and what it is used for

Civerán belongs to a class of medicines known as antihistamines.

Civerán relieves symptoms associated with allergic rhinitis (such as sneezing, runny or itchy nose, and burning or itchy eyes).

Civerán may also be used to help relieve symptoms of urticaria (such as itching, redness, and the number and size of skin wheals).

2. What you need to know before taking Civerán

Do not take Civerán

• If you are allergic to loratadine or to any of the components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Civerán:

• if you have severe liver disease (see section 3. How to take Civerán).
• if you are scheduled to undergo any type of skin allergy testing. Do not take Civerán during the 2 days prior to such tests, as this medicine may interfere with the test results.

Children and adolescents

Use of Civerán with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Civerán and other medicines are known. However, inform your doctor or pharmacist if you are taking, or have recently taken, other medicines, including those obtained without a prescription.

Taking Civerán with food, drinks, and alcohol

Civerán can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is not recommended that you take Civerán if you are pregnant or breastfeeding.

Driving and operating machinery

At the recommended dose, this medicine is not expected to affect your ability to drive or operate machinery. Although most people do not experience drowsiness, it is recommended not to perform activities requiring mental alertness, such as driving a car or operating machinery, until you have determined your individual response to the medicine.

Civerán contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Civerán

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor again.

Adults and children over 2 years of age weighing more than 30 kg:

The recommended dose is one tablet (10 mg) once daily.

Patients with severe hepatic impairment weighing more than 30 kg:

The recommended dose is one tablet (10 mg) once daily on alternate days.

Civerán is not suitable for:

• administration of doses lower than 10 mg.
• administration in patients weighing less than 30 kg.
• patients who have difficulty swallowing.

Use in children and adolescents

Civerán is not suitable for children aged 2 to 12 years with body weight below 30 kg.

The use of Civerán is not recommended in children under 2 years of age.

The tablet score line should not be used to divide the tablet.

If you take more Civerán than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Civerán

If you forget to take a dose at your usual time, take it as soon as possible, then return to your regular dosing schedule. Do not take a double dose to make up for missed doses.

If you interrupt treatment with Civerán

Remember to take your medication.

Your doctor will tell you how long to take Civerán. Do not stop treatment early.

4. Possible adverse effects

Like all medicines, this medicine may have adverse effects, although not everyone experiences them.

The most frequently reported adverse effects (less than 1 in 10 patients but more than 1 in 100 patients) include somnolence, headache, nervousness, fatigue, increased appetite, and difficulty sleeping.

Very rare adverse effects reported (less than 1 in 10,000 patients) have included cases of severe allergic reaction, dizziness, irregular or rapid heartbeat, nausea (feeling sick), dry mouth, stomach discomfort, liver problems, hair loss, skin rash, and fatigue.

Weight gain with unknown frequency.

If you notice these adverse effects or any others not described in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Civerán

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and on the outer packaging following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Civerán

• The active substance is loratadine. Each tablet contains 10 mg of loratadine.
• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose (E 460i), corn starch, pregelatinized corn starch, hydrated colloidal silica (E 551), magnesium stearate (E 470b), hypromellose (E 464), macrogol 400 (E 1521), macrogol 6000 (E 1521), carnauba wax (E 903), talc (E 553b).

Appearance of the medicine and contents of the pack

Civerán is presented as film-coated, round, biconvex tablets with a score on one side and marked "LR10" on the other.

It is packaged in blisters containing 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

NEURAXPHARM SPAIN, S.L.U
Avda. Barcelona, 69
08970 Sant Joan Despí
(Barcelona) – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona, 69
08970 Sant Joan Despí (Barcelona) – Spain

Date of the most recent revision of this leaflet: May 2021

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)